Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy
40 Years
85 Years
Both
Neovascular Maculopathy, Age Related Macular Degeneration
Trial Information
Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy
VEGF receptor 1 and 2 are essential targets to pathogenic angiogenesis, and we identified
that peptides derived from these receptors significantly induce the effective tumor specific
CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the
safety, immunological and clinical response of those peptides. Patients will be vaccinated
once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide
(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. In the
study, our primary aim is to evaluate the safety and tolerability of these peptide vaccine.
The second aim is evaluate the immunological and clinical response of this vaccine therapy.
Inclusion Criteria:
- Neovascular Maculopathy including Age Related Macular Degeneration.
- Resistant against PDT or Anti VEGF therapy or Patient disagree with these therapies.
- with HLA-A*2402 or A*0201
Exclusion Criteria:
- Pregnancy(woman of childbearing potential:Refusal or inability to use effective means
of contraception) Breastfeeding Active or uncontrolled infection Unhealed external
wound Concurrent treatment with steroids or immunosuppressing agent Uncontrolled
brain and/or intraspinal lesion(s) Decision of unsuitableness by principal
investigator or physician-in-charge
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety of this trial will be assessed based on National Cancer Institute-Common Toxicity Criteria,(NCI-CTC) version3. In case grade 4 or more complications occur, we will report the case to the review board within 14 days.
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Kohji Nishida, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Chair of Ophthalmology, Osaka University Medical School
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
08062
NCT ID:
NCT00791570
Start Date:
October 2008
Completion Date:
April 2012
Related Keywords:
- Neovascular Maculopathy
- Age Related Macular Degeneration
- Macular Degeneration
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